Age Appropriate Novel Oral Dosage Form Design of a Third Generation Cephalosporin

Abstract

The better adaptability of a dosage form in all age groups requires an age-appropriate flexible design. The aim of this study was to design an age-appropriate novel oral design of ceftibuten flexible dispersible tablet, a third-generation cephalosporin, as an alternative dosage form design to the commercially available ceftibuten for oral suspension/powder for oral suspension (PFOS) and capsule dosage form. The primary objective of this investigated design was to avoid the necessity of refrigeration and to overcome the limitation in the shelf life of ceftibuten for oral suspension dosage form after reconstitution. The secondary objective of this investigated design was to avoid the impact of the size of the dosage in the condition of swallowing difficulty. The investigated design of ceftibuten flexible dispersible tablet stable at controlled room temperature avoids the necessity of refrigeration and having the flexibility to use either as dispersible tablets or as orodispersible tablets in the condition of swallowing difficulty and based on pathophysiology of salivary secretion. In addition, the investigated design was found acceptable by the age groups covering paediatric to the geriatric population (from 3 years to 80 years) without the necessity of manufacturing different dosage forms. newline